FDA debates expansion of switch paradigm

By Michael Johnsen

Get set for another decade of explosive growth throughout the over-the-counter category with the familiar switch as a catalyst.

The Food and Drug Administration public meeting that took place last month addressed a proposal to expand the switch paradigm by utilizing the latest in communications and diagnostics technology and/or incorporating the most accessible healthcare professional — the retail pharmacist — into the self-care decision protocol.

This would make prescription products available in the OTC space that go well beyond the latest series of complicated switches to hit the market — notably the emergency contraceptive Plan B One Step and Prilosec OTC. Both of those medicines were switched Rx-to-OTC with a dual prescription/nonprescription status. Plan B One Step is still prescription-only for women younger than 17 years, and Prilosec OTC is still prescription-only for a gastroesophageal reflux disease indication. The Drug Facts label on the OTC version instructs users to seek a doctor’s care if needed for more than two weeks.

But what the FDA and others heard over the course of that meeting wasn’t some kind of healthcare science fiction. The stage wasn’t being set for some future OTC Utopia where consumers appropriately self-select an OTC statin every time — the fact is the technology is already in the marketplace. In fact, just about everything needed is in place today, including the back-end infrastructure to support that technology and, on the clinical side, clinical skill sets among pharmacists who are proactively engaging their patients. Unlocking that technology could open up massive new OTC categories — it is projected that an OTC statin class could be worth $1 billion a year.

Market-driven technologies supporting compliance activities are the first to come to mind, suggested Chuck Parker, executive director of the Continua Health Alliance, when considering what tools are in place today that might facilitate a future complex switch. “That’s something that we already have in play in the marketplace,” he said. Something like cholesterol screening — a diagnostic tool that may improve appropriate self-selection of the aforementioned statin remedy — should become available in a retail setting, if not actually sold OTC, in the near future. “We have several companies that are working toward creating a standard to be able to capture that data in a relatively simple format, much like you would do with a glucometer,” Parker said.

The established back end of pharmacy communications also can help facilitate a future expanded switch model. “With the advent of SureScripts, we have a fairly robust and well-connected network now to track prescriptions and [to support] e-prescribing,” Parker said. “The evolution of that technology here in the United States is going to allow us to [engage] two-way communication much more effectively, not only to the physician who’s the prescriber but … [also] to the consumer level.”

In-store diagnostic tools that help improve compliance, contribute to a HIPAA-compliant health record and increase interception opportunities between pharmacists and patients are similarly in place. “We have a live [electronic medical record] today that’s actually sending patients data from the pharmacy directly into the patient’s health record at the physician’s office,” noted Ashton Maaraba, general manager and COO for PharmaSmart International. PharmaSmart has been featuring its Model PS-2000 With Connectivity, an in-store blood-pressure kiosk that integrates a “Smart Card” functionality to enable the transfer of blood-pressure and pulse readings through a secure HIPAA-compliant server and into an online patient health portal. “[This establishes] a link with the acute caregiver with a clinical specialist on-site,” he said. Already, supermarket pharmacies are incorporating that kiosk into their care protocol, Maaraba said, increasing pharmacist-patient interaction, augmenting that healthcare dialogue and then redirecting that patient to the dietitian across the aisle for additional advice on better health.

That pairing of Internet access with a patient identification tool could be a window into one potential future for pharmacy — a future where patients can self-identify a therapeutic need, sit down at a self-serve kiosk, identify themselves and proceed with an interactive online questionnaire to both improve appropriate self-selection and identify next steps. If blood pressure or pulse rates are pertinent, those tests can be administered at the kiosk. And if a patient has appropriately self-selected a therapy, that kiosk can generate a coupon receipt without which the therapy could not be purchased. It’s a self-selection tool that can both redirect a patient to a pharmacist consultation when necessary and pave the way to convenient access when not.

“Our kiosks are already programmed to do most of that,” Maaraba said, “including printing out the coupon.”